bromi variations training meeting 8th may 2008 bromi variations – an industry perspective helen...

BROMI Variations Training Meeting 8th May 2008

BROMI Variations – An Industry Perspective

Helen DarracottDirector of Legal & Regulatory Affairs, PAGB

Gill PeckhamHead of Regulatory Affairs

Johnson & Johnson


An Industry Perspective

• Background

• BROMI principles of self certification

• Implementation of BROMI into the Company

• Key benefits


Background

• BROMI is a more efficient method of managing minor changes

• MHRA time spent approving minor changes was costing Industry time and money

• Industry have the expertise and knowledge to self certify these types of changes

• Aim was to free up MHRA time to concentrate on the more complex and important work

MTanner

3rd bullet point - a la self certification of advertising which has been successfulLast bullet point - maybe non risk / safety related changes rather than important.


In short ….

• The OTC industry was looking for a way to reduce regulatory burdens and increase speed to market


Models of regulation

3rd party approval

Full assessment

Self certificationAdministrative burden reduced


MHRA - A changing role

• Checker • Enforcer


Impact for OTC manufacturers

• Costs– Administrative costs reduced by a

third (£8.1 million)

• Time– Reduced timelines means opportunity

costs can be realised (£100 million)


Other advantages• Better planning • Greater flexibility • Encourages innovation and allows

companies to be responsive to market needs

• For MHRA frees up resource to focus on more complex and important work


BROMI Principles for Self Certification

• Standard operating procedures

• Follow MHRA guidance on BROMI requirements

• Safeguards– Audit and monitoring– (Complaints procedure)

• Sanctions


BROMI Variations

So, How Does it Work?


Variations based on a 3-tier model

Self Certification

Self Certification

Scientific Validation (IA)

Scientific Validation (IA)

30 Day Assessment(IB)

30 Day Assessment(IB)

Type IAType IA Type IBType IB Type IIType II

Pilot for national variations started February 2007


BROMI Variations

So, what do I have to do to utilise the BROMI Scheme?


Company implementation – a new way of working?

• Senior management sign off for increased responsibilities

• Revised SOPs and working practices– for labelling changes we defined who is responsible

for confirming conditions are met– for variations we defined how BROMI changes would

be managed– we prepared necessary submission templates

• Training across the business


Updating Company Procedures

• Follow BROMI principles• Named individual responsible for ensuring

compliance• Maintenance of adequate records to show

the submission and implementation of BROMI changes

• How to assess whether a change is BROMI and which category


Updating Company procedures

• Company tracking documents to show submission and ongoing status of a BROMI change

• How to allocate the correct variation, completion of variation forms and submission of appropriate documentation


Updating Company procedures

• How to manage the change? Implement immediately? Await acknowledgement letters? What triggers advice to other departments that they can implement?

• Event flow following approvals– who to inform – Supply Chain, QP, Manufacturing,

Medical etc– how to track implementation


Implementation• For all the changes that are self certified

we needed to monitor and record the implementation date and this was arranged with the Supply Chain Team


One Company experience – some practical examples

• During 2007 J&J submitted about 160 variations of differing types

• About 100 of these were standard variations

• Since the pilot was introduced a further 60 have been submitted as various BROMI variations


Some practical examples - Variations

Regular62%

BROMI38%

BROMI

Regular



The types of changes include:

• Increase in shelf life

• TSE certificate of suitability updates

• CEP updates for active ingredients

• Amends to EP specifications

• Adding measuring device

• Removal / Change of ink on capsule shell



This year:- – We have to change the name and address

of the company – On about 120 licences, – Including the manufacturing address in about

half the cases



Self Certification BROMI’s are really helping us to manage this project successfully:-

– Using Type 1A Self certification– Prepared stock with new labelling (no risk!)– Submitted self certification just prior to the stock

going onto the market – giving a maximum implementation window

– Allowed maximum flexibility to plan around stock availability


Advantages of BROMI to J&J

In 2007 we submitted• 38% of applications to PIQ as BROMI• 35% of variations as BROMI

We expect these %’s to rise in 2008• as User Testing will be completed and therefore less

standard PIQ submissions.• Name Change project will dramatically increase BROMI

submissions


Advantages of BROMI to J&J

For J&J, BROMI has achieved:- • cost savings• time savings (internally and externally)•increased ability for stock planning,

The BROMI initiative has been one of the most helpful “outputs” from the MHRA in years and has greatly benefited J&J in practice


“The best thing to come out of MHRA for a long time”

“The best thing to come out of MHRA for a long time”

“BROMI has the potential to re-energise the OTC market”

“BROMI has the potential to re-energise the OTC market”

“An incentive

to innovate”“An incentive

to innovate”

“At last I can tell marketing how long something will take”

“At last I can tell marketing how long something will take”

“It’s made such a difference to the way we work”

“It’s made such a difference to the way we work”

“What’s not to like. It’s something that benefits us as well as them”

“What’s not to like. It’s something that benefits us as well as them”

“Everyone wins; we get to market more quickly, people get the medicines they need & MHRA assessors can focus on the things they need to be involved with.”

“Everyone wins; we get to market more quickly, people get the medicines they need & MHRA assessors can focus on the things they need to be involved with.”

bromi variations training meeting 8th may 2008 bromi variations – an industry perspective helen...

Documents

various bromi variations

bromi scheme

standard variations

national variations

implementation slide

variations of differing

market slide

business slide